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Table 4 Illustrative verbatim explanations for the type of review required, by country: cluster-cluster scenario

From: Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

Country Type of review Explanation
Canada Full review Full Board review would be recommended for the following reasons: a) community consent versus individual consent, b) there is an element of deception, c) the treatment/intervention received is determined by randomization, d) the telephone surveys deal with potentially sensitive topic (colorectal screening) and could result in situations where there is a need for follow-up medical and/or psychological care.
  Expedited Review is necessary due to 'research’ component and to ensure privacy and patient rights are protected. Expedited as there is no experimental manoeuvre, screening is according to national guidelines.
  No review The researcher is outside our jurisdiction - They are using subjects who are unlikely to be our patients. At the beginning, consent is not required except at the municipal level. There is no financial liability to the hospital. There is no treatment intervention. I see this as no different from the telephone surveys I receive now at home. It would be polite and professionally correct to bring this to the ethics committee as an FYI. If the researcher wanted to add gravitas to his/her survey they might ask for the 'blessing’ of the ethics committee. However , as before, it not being done on hospital property, involves no patients and no therapeutic intervention.
United Kingdom Full review The exceptions are minimal risk studies with small numbers of participants, which have no contentious issues. In this case, 1,000 participants, approached by random 'cold-call’ telephone with verbal consent required and no prior information, would be rated by us as large and potentially contentious.
  Expedited review The proposed trial deals with a situation where the normal practice is 'no intervention’; there’s no specific bowel screening promotion as described in the UK. Expedited review would be to address whether the materials provided to the Mayors/Officials of the cities involved enough information to understand the proposed research. There is low/no risk to participating citizens and the interventions would be considered 'light touch’ and of low risk; unless of course review of the proposed telephone interview guidelines revealed significant intrusive or alarming questions.
  No review Because it is the effectiveness of the advertising campaign that is to be evaluated and this in itself is not a medical intervention and I would regard the study as in support of delivering an established standard of normal care.
United States Full review I think the questions raised by the methodology, in particular the randomization to a community intervention without individual consent, would merit consideration by the full board.
  Expedited review The study as described presents no more than minimal risk to the sample involved. The dependent measure is related to behavior. The study is not inviting participants to get a colorectal exam offered by the investigators. The study measures are related to the effectiveness of an information campaign.
  No review This is a survey, should be exempt 45 CFR 46.101 #2.